Retinoid-containing medicinal products and Neuropsychiatric disorders: A descriptive analysis of EudraVigilance data

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Description of case series
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ACITRETIN

  ADAPALENE

  ALITRETINOIN

  BEXAROTENE

  ISOTRETINOIN

  TRETINOIN

  TAZAROTENE
• Medical condition to be studied:
  Depression

  Suicidal ideation

  Anxiety
• Additional medical condition(s):
  Psychiatric disorders System Organ Class

Population studied

• Short description of the study population:
  All case of neuropsychiatric disorders reported to any retinoidcontaining medicinal product from inception up to July 2016.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  10295

Study design details

• Main study objective:
  To provide a comprehensive overview of the case reports of neuropsychiatric adverse events associated with the use of retinoid-containing medicinal products.
• Data analysis plan:
  Summary tabulations were produced for the distribution of reports per retinoid, route of administration, reporting year (receive date), location (country), demographic characteristics (age groups, gender), medical history (history of psychiatric disorders) and duration of treatment. Where possible, correlations of the abovementioned variables were provided. To report on relevant MedDRA PTs, Proportional reporting ratios were used as a disproportionality metric and were calculated for each INN and MedDRA PT. This data was analysed cumulatively for all retinoids, stratified by individual retinoid and stratified by route of administration. Output tables were adjusted accordingly. The analysis pertaining to fatal cases resulting from self-injury was presented separately as a subgroup analysis.